As a principle, no batches with Out of Specification (OOS) results should be blended [ICH Q7, Section 8.41]. Blending is defined in [ICH Q7, Section 8.40]. Individual intermediate and/or API batches should demonstrate conformance with the filed specifications prior to blending. In regions or circumstances where there are intermediates and/or APIs that do not require filing, conformance with the release specification should be demonstrated.
